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A Study of ALKS 3831 in Adults With Schizophrenia

NCT01903837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2021-10-06

Study results available
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Summary

This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.

Conditions

Interventions

DRUG

Samidorphan (Low Dose)

Tablets taken once daily

DRUG

Samidorphan (Medium Dose)

Tablets taken once daily

DRUG

Samidorphan (High Dose)

Tablets taken once daily

DRUG

Placebo

Tablets taken once daily

DRUG

Olanzapine

Tablets taken once daily

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Bernard L. Silverman, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • United States
  • Bulgaria
  • Czechia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01903837 on ClinicalTrials.gov